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TABLE OF CONTENTS

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USER GUIDE
BLOOD GLUCOSE MONITORING SYSTEM
TABLE OF CONTENTS

INTRODUCTION���������������������������������������������������������������������������5
DESCRIPTION OF SYSTEM COMPONENTS�������������������������������������7
■■ User interface
■■ Light button and data port
■■ Battery compartment
■■ Test strips
CONFIGURATION�����������������������������������������������������������������������11
■■ Configuration
■■ Date and time
■■ Test reminder
SYMBOL DEFINITIONS���������������������������������������������������������������16
■■ ‘Insert test strip’ notification
■■ Blood sampling notification
■■ Measurement period
■■ Test result
■■ Measurement unit
■■ ‘HI’ notification
■■ ‘LO’ notification
■■ Memory display
■■ Test reminder
■■ Ketone notification
ERROR DEFINITIONS AND RECTIFICATION���������������������������������22
AVERAGE CALCULATION OF MEASUREMENTS�����������������������������24
CONTROL SOLUTION�����������������������������������������������������������������26
■■ Using the control solution
■■ Testing with the control solution
3
TABLE OF CONTENTS

LANCING DEVICE�����������������������������������������������������������������������30
BLOOD LANCET�������������������������������������������������������������������������31
USING THE LANCING DEVICE������������������������������������������������������32
DETERMINATION OF BLOOD GLUCOSE LEVEL�����������������������������34
BLOOD GLUCOSE VALUES FOR ADULTS��������������������������������������36
SYMPTOMS OF LOW BLOOD SUGAR��������������������������������������������37
SYMPTOMS OF HIGH BLOOD SUGAR�������������������������������������������38
POTENTIAL INFLUENCES ON THE MEASUREMENT READINGS�����39
TECHNICAL SPECIFICATIONS – BLOOD GLUCOSE METER������������42
TECHNICAL SPECIFICATIONS – TEST STRIPS������������������������������43
DATA TRANSFER������������������������������������������������������������������������44
LIST OF ITEMS | QUALITY STANDARDS����������������������������������������45
BATTERY REPLACEMENT������������������������������������������������������������46
CLEANING AND MAINTENANCE��������������������������������������������������48
SAFETY AND DISPOSAL��������������������������������������������������������������49
■■ Blood glucose meter
■■ Used test strips, lancets and alcohol swabs
■■ Battery
WARRANTY��������������������������������������������������������������������������������50
EXPLANATION OF SYMBOLS�������������������������������������������������������51
PERSONAL NOTES���������������������������������������������������������������������52

4
INTRODUCTION

Thank you for your trust!

You have chosen the iDia blood glucose monitoring system, which
can be used together with iDia test strips and related accessories
to easily and conveniently measure your blood glucose levels.

The measurement range of the iDia blood glucose monitoring sys-


tem is between 10 – 600 mg/dL or 0.6 – 33.3 mmol/L.

Please ask your specialist physician which unit of measurement


you should use for your therapy.

In order to obtain an accurate blood glucose measurement, you


must follow certain important guidelines.
Therefore, please read this user guide carefully before using the
device for the first time.

You will be amazed at how easy it is to take measurements!

Your blood glucose monitoring system contents:1)


1 iDia Blood glucose meter
and following accessories:
10 iDia Blood glucose test strips
1 IME-DC Lancing device
10 IME-DC UNIVERSAL Blood lancets
1 Kit-Case

1)
The scope of supply of the blood glucose monitoring system (see outer package) can vary depending on state.

5
INTRODUCTION

Before taking your first measurement, please take note of the


following important information.

■■ The iDia blood glucose monitoring system is an in vitro diagnos-


tic tool that is suitable for self-testing. It enables people with
diabetes and specialist medical staff to determine blood glucose
values.
■■ The iDia blood glucose monitoring system is suitable for analys-
ing fresh capillary blood, venous blood, arterial blood or neonatal
blood.
■■ Only use iDia test strips and iDia control solutions. Using other
test strips can lead to incorrect readings.
■■ Close the storage container immediately after removing the test
strip(s).
■■ Check the expiry dates of the test strips and control solution.
■■ Use a new lancet for each blood sample.
■■ Always store the measuring device or test strips according to the
storage requirements, and protect both from moisture, direct sun-
light and other heat sources.
■■ Keep the measuring device and all accessories away from chil-
dren.
■■ Clean your iDia blood glucose monitoring system regularly.
■■ The functioning of the iDia blood glucose monitoring system
can only be guaranteed if it is used correctly and for its intended
purpose.
■■ Blood glucose monitoring systems must not be used for diabetes
diagnosis.

6
DESCRIPTION OF SYSTEM COMPONENTS

USER INTERFACE

Test strip slot

Display

Main button

7
DESCRIPTION OF SYSTEM COMPONENTS

LIGHT BUTTON AND DATA PORT

Light button

Data port

Pressing the light button when the blood glucose monitoring


system is switched on will activate the display's blue background
lighting. This makes it possible to take and read measurements
correctly even in low light conditions.
8
DESCRIPTION OF SYSTEM COMPONENTS

BATTERY COMPARTMENT

Battery

Set button

Battery

9
DESCRIPTION OF SYSTEM COMPONENTS

TEST STRIPS

MEASUREMENT FIELD

Application area
Touch the drop of blood with the appli-
cation area. The blood will be absorbed
automatically.

Test area
This area must be completely filled with
the blood sample.

Measurement contacts
Insert the test strip into the test strip slot,
with the measurement contacts first.

NOTE
You can touch the measurement field of the iDia test strips freely
with clean, dry hands. The test result will not be affected.
10
CONFIGURATION

CONFIGURATION

Set button

First remove the battery cover and check that the required 3 V lith-
ium batteries (type CR 2032) have been inserted. If this is not the
case, you will need new batteries (see page 46).

Then set the current date and correct time. To do this, press the set
button (using a pen, for example), and then press the main button
(this changes the flashing value on the display).

NOTE
Please be prepared for necessary battery changes by keeping two
spare batteries with you (Type CR 2032).
11
CONFIGURATION

DATE AND TIME

NOTE
The figures needing adjustment flash on and off (shown in white in
the illustrations).

1 2 3

4 5

1 Set button pressed once: The blood glucose meter switches


itself on. ‘Year’ setting
2 Set button pressed second time: ‘Month’ setting
3 Set button pressed third time: ‘Day’ setting
4 Set button pressed fourth time: ‘Hour’ setting
5 Set button pressed fifth time: ‘Minute’ setting

12
CONFIGURATION

TEST REMINDER

6 7 8

9 10 11

6 – 10 Set button pressed sixth to tenth times:


‘Test reminder’ setting: up to five different test reminder times
can be set (see page 14).
11 Set button pressed eleventh time: The blood glucose meter
switches itself off.

Finally, place the battery cover on the device.

NOTE
If you change settings using the set button and main button, you
will need to go through all of the settings until the blood glucose
13
CONFIGURATION

meter switches itself off (after pressing the set button for the last
time).
Your changes will only be saved after this step.

Your iDia blood glucose monitoring system can issue an alarm tone
five times a day to remind you to check your blood glucose level.

After pressing the set button six times (see page 13) you can set
five different times for test reminders.

12 13

The main button can be used to turn the test reminder function
on (12) or off (13).

14
CONFIGURATION

When the test reminder function is activated, you will be prompted


to enter the first of your preferred times. Press the set button and
then use the main button to set the desired hour (14) and minute (15),
and confirm by pressing the set button again.

14 15

After setting the first test reminder, it is possible to set four further
test reminders.

NOTE
You will be reminded to take your measurement by an alarm tone.
To complete the process, press the main button for 1 second.

15
SYMBOL DEFINITIONS

16 17

‘INSERT TEST STRIP’ NOTIFICATION


16 After the iDia blood glucose monitoring system has been
switched on with the main button, the test strip symbol will
appear in the display. You should now insert the test strip into
the device’s test strip slot. Correct insertion of the test strip will
be confirmed by an audio signal.

BLOOD SAMPLING NOTIFICATION


17 Once the test strip has been inserted into the test strip slot, the
blood intake symbol appears in the display. You now have three
minutes to perform a blood glucose measurement. If no blood
sampling takes place within this time, the iDia blood glucose
meter will switch itself off automatically.

16
SYMBOL DEFINITIONS

18

MEASUREMENT PERIOD
18 Measurement begins once the test area of the test strip is
sufficiently filled with blood, and lasts only 7 seconds. During
the measurement, an hourglass animation is visible on the
display.

17
SYMBOL DEFINITIONS

TEST RESULT
7 seconds after the start of the measurement, the blood glucose
value will be displayed and automatically saved, together with the
date and time (19 and 20).

19 20

MEASUREMENT UNIT
This will be displayed together with the measurement reading
(21 and 22).

21 22

18
SYMBOL DEFINITIONS

‘HI’ NOTIFICATION
This will appear if the measured blood glucose value exceeds
600 mg/dL or 33.3 mmol/L (23 and 24).

23 24

‘LO’ NOTIFICATION
This will appear if the measured blood glucose value is below
10 mg/dL or 0.6 mmol/L (25 and 26).

25 26

NOTE
If you receive a ‘HI‘ or ‘LO‘ notification, repeat the measurement
procedure. If the notification appears again, perform a measure-
ment using the control solution (see page 26 onwards) or contact
your specialist physician.

19
SYMBOL DEFINITIONS

MEMORY DISPLAY
The iDia blood glucose meter can save up to 900 blood glucose
measurements, along with the date and time of each. Blood glu-
cose measurements and control solution measurements are stored
separately. If the user exceeds the memory capacity, each addi-
tional measurement will automatically overwrite the oldest saved
blood glucose value.
After switching on the blood glucose monitoring system and then
pressing the main button, the last blood glucose meter taken will
be displayed with its corresponding date and time (27 and 28). By
pressing the main button again, other saved measurement results
can be recalled.

27 28

20
SYMBOL DEFINITIONS

29 30

TEST REMINDER
29 If the test reminder function is activated, this will be indicated by
an alarm symbol on the display when the blood glucose moni-
toring system is switched on (see also page 15).

KETONE NOTIFICATION
30 If the measured blood glucose value exceeds 300 mg/dL or
16.7 mmol/L, the ketone notification will be automatically dis-
played, which warns you of a potential ketoacidosis.

For more detailed information about ketoacidosis, please consult


with your specialist physician.

21
ERROR DEFINITIONS AND RECTIFICATION

31 32

The following errors will be shown on the display with an ‘Err‘ or


‘EEE‘ notification:

31 Err + battery symbol


■■ Not enough battery power
Change the battery (see page 46 onwards).

32 Err + thermometer symbol


■■ The ambient temperature is outside the acceptable temperature
range.
The operating temperature must be between +10 °C and +40 °C.

22
ERROR DEFINITIONS AND RECTIFICATION

33 34

33 EEE
■■ Electronic error
In this case, please contact IME-DC customer service.

Service hotline: +49 9281 | 85 01 6-0

34 Err + test strip symbol


■■ Test strip malfunction
■■ Used test strip
■■ Not enough blood absorbed
■■ Not enough control solution absorbed
■■ The blood was absorbed before the blood sample symbol ap-
peared in the display.
Repeat the measurement with a new test strip.

23
AVERAGE CALCULATION OF MEASUREMENTS

Your iDia blood glucose meter allows you to call up and display the
average values of the last 24 hours and the past 7, 14, 21, 28, 60 and
90 days.
To do this, please activate the memory display (35) (see page 20).
Simultaneously press the main button and light button and hold
them for approximately 2 seconds. The average value of the last
24 hours is displayed (36).

Each time you press the main button again, the average values for
other periods (the past 7, 14, 21, 28, 60 or 90 days) will be displayed
(37 - 42).

To return to the memory display (43), press the main button and
light button simultaneously and hold them for 2 seconds again.

24
AVERAGE CALCULATION OF MEASUREMENTS

35 36 37

38 39 40

41 42 43

25
CONTROL SOLUTION

USING THE CONTROL SOLUTION


Test measurement with the iDia control solution is used to check
that the blood glucose monitoring system is functioning correctly.

This procedure is recommended in the following cases:


■■ For teaching and training purposes
■■ If the blood glucose meter or the blood glucose test strips have
been stored at an inappropriate temperature
■■ Following improper handling of the blood glucose meter
■■ In the event of questionable blood glucose readings

NOTES
■■ The control solution must not be used after the expiry date.
■■ When the control solution bottle is first opened, the date must be
written on the label.
■■ The shelf life of the control solution is 90 days after it is first
opened.
■■ Always take care that the control solution is used correctly.

26
CONTROL SOLUTION

TESTING WITH THE CONTROL SOLUTION


Insert an iDia test strip into the test strip slot. The blood glucose
monitoring system will switch itself on automatically.

44 45

44 The display will now prompt you to take a blood sample.


45 Press the main button and hold it for approximately 2 seconds
until the control solution symbol appears in the display.

You are now in the designated control solution measurement


mode. In this mode, measurement results of the control solution
are saved separately.
This prevents the average values of your personal blood glucose
measurements being falsified by the control solution measure-
ments.

27
CONTROL SOLUTION

Next, rotate the control solution bottle 3 – 4 times.


Please don’t shake it!

46 47

46 After opening the bottle, put a drop of control solution on a


clean, dry surface (for example, the lid of the test strip contain-
er), at a distance of approximately 2 cm. Then close the bottle.
Use a new drop of control solution for each measurement.
47 Now place the application area of the test strip on the drop of
control solution, until the test area is completely filled. An audio
signal will confirm the start of the measurement.

28
CONTROL SOLUTION

48 49

After 7 seconds, the measurement reading will be shown together


with the date, time, measurement unit and bottle symbol (48 and 49).
The measurement reading should fall within the appropriate target
range (see test strip container label).

The test result lies outside the control range


If an error message is displayed during measurement, or if the
measured value is outside the target range (as shown on the test
strip container), repeat the measurement. If an error message ap-
pears again or if the measurement is again outside the target range,
please contact IME-DC customer service.

Service hotline: +49 9281 | 85 01 6-0

29
TABLE OFDEVICE
LANCING CONTENTS

Lancing device cap

Lancing device regulator


(can be adjusted individually)

Slot

Activation button

Spring clip

30
TABLEBLOOD
OF CONTENTS
LANCET

Protective cap

Lancet

Lancet body

31
USING THE LANCING DEVICE

50 51 52

53 54 55

50 Unscrew the lancing device cap.

51 Insert the lancet into the slot.

52 Twist off the lancet protection cap.

53 Screw the lancing device cap back on.

54 Set your personal puncture depth (minimum 1, maximum 5).

55 Load the lancing device by pulling the spring clip back.

32
USING THE LANCING DEVICE

56 57 58

59 60 61

56 Press the tip of the lancing device against your finger and press
the activation button.

57 The blood drop obtained can be used for the measurement


procedure.

58 Unscrew the lancing device cap.

59 Press the lancet into the protective cap.

60 Slide the spring clip forward sharply, to eject the lancet.

61 Screw the lancing device cap back on.

33
TABLE OF CONTENTS
DETERMINATION OF BLOOD GLUCOSE LEVEL

62 63 64

62 Only use iDia test strips for the iDia blood glucose meter.

63 Wash your hands with warm water and dry them well before
taking a measurement.

64 Insert the test strip into the test strip slot on the iDia blood
glucose meter. The blood glucose meter system will switch itself
on automatically.
If the temperature is within the permitted range, the blood
glucose meter will prompt you to touch the blood drop with the
application area (see page 10).

Now use the lancing device to obtain a blood drop (see 50 – 61 from
page 32 onwards).

34
DETERMINATION OF BLOOD
TABLE
GLUCOSE
OF CONTENTS
LEVEL

65

Position the application area of the iDia test strip to the blood drop
(65). The blood will be absorbed automatically. An audio signal will
confirm that measurement has started.

66 67

After 7 seconds, the measurement reading will be displayed and


saved automatically, together with the date, time and unit of
measurement (66 and 67).

35
TABLE OF
BLOOD GLUCOSE
CONTENTS
VALUES FOR ADULTS

Blood glucose values for adults1


(Reference sample type: venous plasma)

without diabetes with diabetes

≤ 100 mg/dL ≥ 126 mg/dL


Empty stomach
≤ 5.6 mmol/L ≤ 7.0 mmol/L

≤ 140 mg/dL ≥ 200 mg/dL


2 hours after a meal
≤ 7.8 mmol/L ≤ 11.1 mmol/L

1
R. Landgraf et al., 2013: Praxisempfehlungen DDG/DGIM [Recommended prac-
tice – German Diabetes Association/German Association for Internal Medicine];
Diabetologie und Stoffwechsel [Diabetology and metabolism]; Thieme Verlag

36
SYMPTOMS OFTABLE
LOW BLOOD
OF CONTENTS
SUGAR

If possible, take an immediate measurement of your blood glucose


value if any of the following symptoms2 occur (possible high or
low blood sugar). Contact your specialist physician immediately
(or have somebody contact them for you) for instructions on what
actions to take.

Symptoms of low blood sugar (hypoglycaemia):


■■ Sweating
■■ Intense hunger
■■ High heart rate
■■ Tingling lips
■■ Slight difficulties with concentration
■■ Mood swings
■■ Trembling (in some circumstances all over the body)
■■ Distorted vision (e.g. flickering)
■■ Disorientation, difficulty with targeted thinking or action
■■ Unconsciousness
■■ Cramps

2
G.-W. Schmeisl, Schulungsbuch für Diabetiker [Training manual for diabetics],
Urban & Fischer Verlag/Elsevier GmbH, 5th edition, 2005

37
TABLE OF CONTENTS
SYMPTOMS OF HIGH BLOOD SUGAR

Symptoms of high blood sugar (hyperglycaemia):


■■ Fatigue
■■ Listlessness
■■ Frequent urination and thirst
■■ Weight loss
■■ Weak muscles, leg cramps
■■ Itchiness
■■ Dizziness, vomiting, stomach ache
■■ Acetone odour (like nail polish remover) in exhaled air
■■ Unconsciousness

NOTE
If your blood glucose measurement value is less than 50 mg/dL
(2.8 mmol/L) or more than 250 mg/dL (14.0 mmol/L), contact your
specialist physician immediately.

38
POTENTIAL INFLUENCES ON THE MEASUREMENT
TABLE OF CONTENTS
READINGS

Potential influences on the measurement readings


■■ The blood for sampling was squeezed out of the finger using
strong pressure and therefore contains tissue fluids.
■■ The expiry date of the blood glucose test strips has passed.
■■ The blood glucose test strips were stored at unsuitable tempera-
tures (acceptable storage temperatures are between +4 °C and
+32 °C).
■■ The test strips were not sufficiently protected from moisture.
■■ If disinfection was performed, the disinfectant was not allowed to
evaporate completely.
■■ You did not wash your hands before taking the blood glucose
measurement.
■■ You did not dry your hands before taking the blood glucose mea-
surement.
■■ Excessively high blood pressure can result in inaccurately low
measurement values.
■■ Severely ill patients should not be tested with blood glucose mon-
itoring systems.

If inexplicable measurement results occur frequently, please con-


tact your specialist physician.

Interferences
Endogenous substances in the human body such as bilirubin, uric
acid, glutathione, triacylglycerol and cholesterol, in addition to the
medical substances shown in the table, do not have a significant
effect on the blood glucose monitoring results from the iDia blood
glucose meter if they do not exceed normal concentrations orth-
erapeutic dosages. If this is not the case, it can lead to incorrect
results.
39
TABLE OF CONTENTS
POTENTIAL INFLUENCES ON THE MEASUREMENT READINGS

Substance Interference from


Paracetamol > 18 mg/dL
Bilirubin > 20 mg/dL
Pralidoxime iodide > 200 mg/dL
Triacylglycerol > 1000 mg/dL
Cholesterol > 300 mg/dL
Glutathione > 74 mg/dL
Uric acid > 20.4 mg/dL

If haematocrit values are less than 20 %, it is possible that an


inaccurately high blood glucose value is displayed. If haematocrit
values are more than 70 %, it is possible that an inaccurately low
blood glucose value is displayed.

When measuring EDTA-treated blood samples with the iDia blood


glucose meter, the blood glucose values recorded may differ from
those of an untreated blood sample. Therefore, the use of sample
tubes treated with lithium-heparin is recommended.

40
POTENTIAL INFLUENCES ON THE MEASUREMENT
TABLE OF CONTENTS
READINGS

NOTE
Our IME-DC customer service department is happy to answer any
questions you may have.

Other information
■■ Please do not make any medically significant decisions without
consulting your specialist physician first.

■■ Clinical institutions and professional caregivers: Please dispose of


used test strips according to your employer’s instructions. Please
note that used test strips may represent an infectious hazard.

■■ Private users: Please dispose of used test strips according to local


regulations.

■■ To check that the blood glucose monitoring system is functioning


correctly, you have the option of carrying out measurements with
the iDia control solutions (available separately).

41
TECHNICAL SPECIFICATIONS – BLOOD GLUCOSE METER

Amperometric biosensor system with addi-


Functionality:
tional alternating current measurement
Dimensions: 90 × 52 × 15 mm
Weight: 58 g
Power supply: 2 × 3 V lithium battery (CR 2032)
iDia blood glucose meter is suitable for
Device type:
long-term use
Measurement range: 10 – 600 mg/dL or 0.6 – 33.3 mmol/L
Measurement period: 7 seconds
Operating environment: +10 °C to +40 °C
Storage temperature: -20 °C to +70 °C
900 measurement values with time and
date; Blood glucose measurements and
Measurement memory:
control solution measurements are stored
separately
Type: Hand-held device
After three minutes if test strips are insert-
Automatic shutdown:
ed, otherwise after one minute of inactivity
Display: LCD with blue background lighting
Patented dynamic measurement method,
screen menu, automatic system check,
electrode insertion sensor, temperature
Technology:
warning, ketone notification, test reminder
function, average calculation of measure-
ments, automatic startup and shutdown

42
TECHNICAL SPECIFICATIONS – TEST STRIPS

Dimensions: 30 × 6 mm
Material: PET
Measurement method: Electrochemical/dynamic
Enzyme: GDH-FAD
Required blood volume: 0.7 µL
Fresh capillary blood, venous blood,
Sample type:
arterial blood or neonatal blood
Calibration: Plasma equivalent
Haematocrit range: 20 ‒ 70 %
Measurement temperature: +10 °C to +40 °C
Storage temperature: +4 °C to +32 °C
Relative humidity: < 85 %
18 months (from date of manufacture)
Shelf life:
After opening: 180 days

Suitable for clinical or private use!

Chemical composition:
■■ 21.8 % Glucose dehydrogenase flavin adenine dinucleotide
■■ 41.6 % Potassium ferricyanide
■■ 36.6 % Non-reactive ingredients

43
TABLETRANSFER
DATA OF CONTENTS

All saved measurement results can be transferred to and managed


on a PC using appropriate software. Only use the IME-DC USB data
cable for this purpose.

68 69

Insert the USB data cable into the USB port on your PC. Open a
compatible data transfer program on your PC. When prompted,
make sure that the blood glucose meter is switched off, and insert
the USB cable jack into the data port on the device (68). Now start
transfer of the data saved on the device (69).

NOTE
The basic requirement for data transfer is recognition of the blood glucose
meter by the data transfer program. If the iDia blood glucose meter is not yet
listed there, please contact IME-DC customer service. If data transfer is still not
possible e ven when your computer does recognise your device, this could be
due to missing drivers.
A list of additional drivers can be found on our homepage at www.imedc.de
under ‘Downloads‘.

44
LIST OF ITEMS | QUALITY
TABLE OFSTANDARDS
CONTENTS

List of items EAN code


iDia IME-DC blood glucose monitoring system set (mg/dL) 4260155930171
iDia IME-DC blood glucose monitoring system set (mmo/L) 4260155930201
iDia IME-DC blood glucose test strips 4260155930188
iDia IME-DC control solution (level 1/level 2) 4260155930195
IME-DC lancing device 4260155930065
IME-DC UNIVERSAL blood lancets 4260155930058
IME-DC USB data cable 4260155930041
3 V lithium battery (CR 2032) 4260155930072

Quality standards
■■ Directive 98/79/EC of the European Parliament and of the Council
of 27 October 1998 on in vitro diagnostic medical devices
■■ EN 60601-1/IEC 60601-1: Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance
■■ EN 60601-1-2/IEC 60601-1-2: Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic disturbances
- Requirements and tests
■■ EN 61010-1/IEC 61010-1: Safety requirements for electrical
equipment for measurement, control, and laboratory use - Part 1:
General requirements
■■ DIN EN ISO 15197: In vitro diagnostic test systems – Requirements
for blood-glucose monitoring systems for self-testing in managing
diabetes mellitus

45
BATTERY REPLACEMENT

70

If the display shows the error message ‘Err + Battery symbol’, or if


the device no longer switches itself on, the battery needs to be
changed (70).

71 72

71 Remove the battery cover.


72 To remove the battery, lightly press it towards the right until the
battery is no longer held by the two plastic tabs on the left-hand
side. Afterwards you can remove the battery by lifting it up
(left-hand side first).

46
BATTERY
TABLEREPLACEMENT
OF CONTENTS

73 74

73 To fit a new battery, first slide it (plus icon up) underneath the
metal brackets (from left to right).
Using your thumb, insert the battery with light pressure towards
the left. The battery should now be held by all four tabs.
74 Close the battery cover.

NOTES
■■ After inserting the new batteries, the device will switch to setup
mode, and the figures indicating the year will flash on the display.
■■ Check the time and date settings, and refresh these if necessary
(see page 12 onwards).
■■ If no changes are necessary, wait until the device shuts itself off
automatically (after approximately 1 minute).
■■ Your saved measurements will not be lost after battery change.
■■ Please use only 3 V CR 2032 batteries.

47
TABLE OF CONTENTS
CLEANING AND MAINTENANCE

■■ Use a soft cloth to clean the blood glucose monitoring system.

■■ Do not use any strong cleaning agents for cleaning the device.

■■ The outer surfaces of the blood glucose monitoring system may


be disinfected using standard disinfectant wipes.

■■ Avoid heavy contamination.

NOTE
Handle your device with care.

48
SAFETY
TABLEAND
OF CONTENTS
DISPOSAL

BLOOD GLUCOSE METER


■■ Do not use the blood glucose meter in close proximity to other
electrical devices, in order to avoid possible electromagnetic
interference.
■■ Used blood glucose meters may have traces of blood on them and
therefore potentially represent infectious hazard.
■■ Remove the battery prior to disposal.
■■ Dispose of the blood glucose meter according to local regulations.

USED TEST STRIPS, LANCETS AND ALCOHOL SWABS


■■ Used test strips, lancets, and alcohol swabs (or similar materials)
may be infectious. It is therefore important to treat used materials
as infectious or biohazardous waste.
■■ Please dispose of these materials according to local regulations.

BATTERY
■■ Prior to use, check that the battery cover is closed.
■■ Use only the recommended battery type (CR 2032). Other battery
types can damage the device.
■■ Dispose of batteries according to local regulations.
■■ Never dispose of batteries in a fire.

49
WARRANTY

iDia blood glucose meter

5-YEAR WARRANTY

IME-DC GmbH hereby guarantees correct functioning of the iDia


blood glucose meter for a period of 5 years, starting from the date
the device is activated. If any faults occur during this warranty
period, you will be provided with a new device at no extra cost.
This offer is contingent upon appropriate use of the blood glucose
monitoring system for the intended purposes. No guarantee can be
made for improper use.

Please note: The warranty does not take effect until the device
has been activated. Therefore, after you take delivery of the blood
glucose monitoring system, fill out the warranty card in full and
send it to:
IME-DC GmbH, Fuhrmannstrasse 11, 95030 Hof, Germany

NOTE
A warranty can only be honoured if the iDia blood glucose monitor-
ing system has been used correctly and for its intended purpose. To
make a warranty claim, contact the responsible dealer, or contact
IME-DC GmbH directly.

50
EXPLANATION OF SYMBOLS

Article number

Lot number

Serial number

In vitro diagnostic tool

Follow user instructions

Can be used until

Manufacturer

Date of manufacture

Do not reuse

Temperature limits

Keep dry

Keep away from sunlight

Important: read product documentation

This product meets the requirements of the IVD Directive in


accordance with 98/79/EC
Class II device in accordance with Standard 60601-1 Applied
Part Type B

Dispose of device separately according to local regulations

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TABLE OF CONTENTS
PERSONAL NOTES

52
TABLE
PERSONAL
OF CONTENTS
NOTES

53
TABLE OF CONTENTS
PERSONAL NOTES

54
IME-DC GmbH
International Medical Equipment -
Diabetes Care
P003006ENXX0501XX00B

Fuhrmannstrasse 11
95030 Hof | Germany
Version: 2018-05

Tel.: +49 9281 | 85 01 6-0


Fax: +49 9281 | 85 01 6-100
E-mail: info@imedc.de
Website:www.imedc.de